Manager, QA & Continuous Improvement

About the role

The Manager, Quality Assurance & Continuous Improvement is responsible for managing the Quality Assurance team across the function. This role oversees the Quality System, including owning and operating the Monthly Review Board (MRB), CAPA program, and managing all aspects of the Quality Monitoring program. It also maintains the documentation control system to ensure proper controls and accountability and supports internal and external audits. The position drives the quality and continuous improvement strategy while managing an organization of quality assurance and data-driven insights personnel.

Responsibilities

• Manages the Quality Assurance team, responsible for selection and hiring, setting performance expectations, and development of staff.
• Assists with the overall development and implementation of organizational Performance Improvement (PI) plan, including identification of PI goals, coordinating and participating in PI projects, and reporting activities and outcomes.
• Manages investigations (ERs), including oversight of complaints, non-conformances, CAPA and deviations, identifying improvements and responding to trends.
• Manages quality and performance metrics and Key Performance Indicators (KPIs) for the larger function, utilizing trend and data analytics to prioritize areas of opportunity, and leading projects and efforts to drive improvements.
• Reviews and approves Quality System documents and records.
• Manages organizational Risk Management process, partnering with OEC and BTS in driving improvement in privacy and security efforts.
• Supports internal and external audits, provides audit responses, and develops improvement plans based on audit feedback.
• Responsible for monthly Management Review Board (MRB) meeting, collaborating with quality team and larger organization in presenting quality trends, remediation efforts, and impact metrics.
• Oversees monitoring tools and supports expansion of automated quality monitoring and analytics where appropriate.
• Supports other functional quality initiatives, programs, and systems as required.

Qualifications

• Bachelor’s degree in business, physical or life science, pharmacy, nursing, engineering, or related field if combined with relevant work experience.
• 5+ years experience in quality assurance, service center, or technical field in a regulated industry or relevant experience.
• 3+ years of managerial and/or project management experience in a quality assurance or similar organization highly desired.
• Knowledge of AbbVie Quality System or similar, specifically governing policies and procedures related to Quality Assurance best practices.
• Experience driving key process improvement initiatives based on data-driven insights and key performance indicators (KPIs).
• Ability to represent the Quality function effectively with senior managers, other AbbVie, and external professionals.
• Strong communication skills and ability to effectively collaborate with stakeholders across the organization.
• Six Sigma / continuous improvement methodology, certification, or experience is preferred.
• Regulatory, compliance, and/or information security experience is desired.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in long-term incentive programs.